Abstract: Embodiments herein relate to active agent depots formed in situ and related methods. In various embodiments, a method of forming an active agent depot in situ is included. The method can include contacting a composition with a vessel wall, wherein the composition includes an active agent and a fibrin promoting vessel wall transfer agent wherein the ratio of active agent to fibrin promoting vessel wall transfer agent (wt./wt.) is at least 5:1. The method also includes transferring the composition from a device surface to the vessel wall surface. The method also includes forming a fibrin matrix around the composition. Other embodiments are also included herein.

Abstract: In an example, a scoring device is configured for retention of a catheter shaft. The scoring device incudes a proximal portion and a distal portion. A retention sleeve extends between the proximal and distal portions. The retention sleeve has a catheter socket configured to selectively receive and mechanically engage the catheter shaft. The scoring device includes a scoring tool coupled with the retention sleeve, for instance proximate to the distal portion. The scoring tool includes a balloon socket configured to selectively receive a balloon of the catheter shaft. The scoring tool includes one or more scoring elements extending around the balloon socket, the one or more scoring elements configured to provide localized scoring to vasculature.

Abstract: Embodiments of the invention include drug delivery coatings and devices including the same. In an embodiment, the invention includes a drug delivery coating including a polymeric layer. The polymeric layer can include a hydrophilic outer surface. The coating can also include a matrix contacting the hydrophilic outer surface. The matrix can include a particulate hydrophobic therapeutic agent and a cationic agent. The polymeric layer can further include a hydrophilic polymer having pendent photoreactive groups and a photo-crosslinker including two aryl ketone functionalities. Other embodiments are also included herein.

Abstract: An anchored dilator includes a push tube having proximal and distal push tube portions. A dilator tip is coupled with the distal push tube portion and is configured for selectable coupling with a catheter. The dilator tip includes an anchor cuff having a cuff interface. The anchor cuff is configured to transition between a shuttle configuration having a shuttle profile and an anchored configuration having an anchored profile larger than the shuttle profile. A cuff operator assembly is configured to transition the anchor cuff between the anchored and shuttle configurations. The cuff operator assembly includes a cuff operator movably coupled with the dilator tip, and an operator shaft coupled with the cuff operator. The operator shaft extends toward the proximal push tube portion. Actuation of the cuff operator with the operator shaft transitions the anchor cuff between the shuttle configuration and the anchored configuration.

Abstract: Embodiments of the disclosure include coatings comprising an oligomerized polyphenol layer. The oligomerized polyphenol layer can be used as an intermediate coated layer on a medical device that hydrogen bonds to a synthetic or natural polymer, which in turn can be used as a top coat or further associated with another coated layer. The multilayered coatings can provide properties such as hemocompatibility or lubricity. In other embodiments, the oligomerized polyphenol layer is used on a medical device as a hemostatic layer configured to contact blood and promote coagulation. The oligomerized polyphenol layer can also be used on the inner surface (e.g., inner diameter) of a medical device to prevent bacterial adherence. The oligomerized polyphenol layer can also be used on the surface of a in vitro diagnostic article, or a cell culture device to, promote adsorption of a biological molecule.

Abstract: Embodiments of the invention include lubricious medical device coatings. In an embodiment the invention includes a coating for a medical device including a first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; and a first cross-linking agent comprising at least two photoreactive groups; a second layer disposed on the first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; a second cross-linking agent comprising at least two photoreactive groups; and a polymer comprising polyacrylamide, the polymer derivatized with at least one photoreactive group. Other embodiments are included herein.

Abstract: Aspects herein relate to apparatus and methods for coating medical devices. In an embodiment, a coating system is included having a two-part fluid applicator defining a central channel, the two-part fluid applicator can include a first part having a first degree of flexibility; and a second part having a second degree of flexibility. The system can further include a fluid supply conduit in fluid communication with the fluid applicator; and a fluid supply reservoir in fluid communication with the fluid supply conduit. Other embodiments are also included herein.

Abstract: Aspects herein relate to a low-friction septum for providing a leak-resistant seal for use in a vascular access device. In an embodiment, a device for vascular access hemostasis is included having an enclosure defining a cavity and configured to at least partially receive a medical device. The device can include a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The device can include a barrel in structural communication with the second seal portion, the second seal portion including a septum seal. The second seal portion can define two or more discrete portions, each separated by one or more split lines. The discrete portions can include a mating surface to interface with mating surfaces of other discrete portions. The mating surface can include a surface topology including raised portions and depressions. Other embodiments are also included herein.

Abstract: The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body, and that can provide advantages in terms of balloon insertion, safety, and drug delivery. The insertion tool includes a tubular portion that accommodates a balloon portion of a balloon catheter, and one or more separation margin(s) in the wall of the tubular portion or one or more split(s) in the tubular wall. The insertion tool also includes a proximal tab that extends from a second lengthwise half having a portion at an angle skew to the lengthwise axis, or that is in the form of a solid article comprising a concave surface that is fastened to an outer surface of the second lengthwise half of the tubular portion; or first and second tabs that extend from first and second lengthwise halves of the tubular portion, respectively.

Abstract: Embodiments of the invention include apparatus and methods for coating drug coated medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit. The coating application unit can include a fluid applicator having a lengthwise axis and a width. The fluid applicator can include a tip comprising a first face across the width of the fluid applicator. The first face of the fluid applicator can be oriented at an angle of from about 15 to about 75 degrees with respect to the lengthwise axis of the fluid applicator. The fluid applicator can define a second face intersecting the first face. The coating apparatus can further include a rotation mechanism and an axial motion mechanism. Other embodiments are also included herein.

Abstract: The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body. In embodiments the insertion tools have an elongate hollow body (50) that is able to protect a portion of a medical device, such as a balloon of a balloon catheter, during an insertion procedure. In one embodiment the insertion tool has an elongate hollow body (131), a tapered distal end (135), and a locking mechanism (133) at the proximal end which can secure a portion of a balloon catheter. An opening at the distal end can allow passage of the balloon in a folded uninflated state.

Abstract: A catheter assembly includes a catheter shaft having shaft proximal and distal portions. A hub is coupled with the catheter shaft proximate the shaft proximal portion. A graduated strain relief fitting is coupled between the catheter shaft and the hub. The graduated strain relief fitting includes at least a first flexural modulus proximate the hub and a fitting proximal portion. The graduated strain relief fitting includes a second flexural modulus proximate the catheter shaft and a fitting distal portion. The second flexural modulus is less than the first flexural modulus and less than or equal to a catheter shaft flexural modulus. The first and second flexural moduli are modulated with one or more of a taper, flexure joints, fitting frame of the fitting or material of the fitting body.

Abstract: Embodiments of the invention include drug delivery coatings and devices including the same. In an embodiment, the invention includes a drug delivery coating including a polymeric layer. The polymeric layer can include a hydrophilic outer surface. The coating can also include a matrix contacting the hydrophilic outer surface. The matrix can include a particulate hydrophobic therapeutic agent and a cationic agent. The polymeric layer can further include a hydrophilic polymer having pendent photoreactive groups and a photo-crosslinker including two aryl ketone functionalities. Other embodiments are also included herein.

Abstract: The disclosure provides plaque treatment catheter assemblies for the treatment of arterial plaques and removal of clots. One assembly includes a second catheter tube movable within a first catheter tube, and an expansion member movable within the second tube. The second catheter tube has one or more distally-disposed and outwardly-expandable plaque treatment portion(s). Another assembly includes a catheter tube and at least one channel(s) within the catheter. The channel includes an elongate member with a distally-disposed plaque scoring or clot retrieval member. Optionally, the assembly includes an expandable member that can cause movement of the scoring member.

Abstract: Aspects herein relate to coating apparatus and methods for coating medical devices. In an embodiment, a coating system is included having a valve, a fluid supply reservoir in fluid communication with the valve, a reciprocating positive displacement pump in fluid communication with the valve, and a fluid applicator in fluid communication with the three-way valve. The valve can be configured to assume a first fluid transport state and a second fluid transport state, wherein the valve provides fluid communication between the fluid supply reservoir and the reciprocating positive displacement pump when in the first fluid transport state for filling of the reciprocating positive displacement pump, and wherein the valve provides fluid communication between the reciprocating positive displacement pump and the fluid applicator when in the second fluid transport state for applying a coating suspension to a medical device surface. Other embodiments are also included herein.

Abstract: The present invention relates to a pharmaceutical composition for intravascular delivery of a therapeutic agent, such as paclitaxel, rapamycin, or an analog thereof. The composition includes the therapeutic agent and a biocompatible solvent, such as glycofurol. The composition can aid tissue penetration by the therapeutic agent. A catheter assembly that protects the pharmaceutical composition from the surroundings can be used for its intravascular delivery.

Abstract: A hemodialysis vascular access device includes a proximal end sized and shaped to sealably couple to a hemodialysis catheter, a movable structure coupled to the proximal end, a fixation structure coupled to the movable region and sized and shaped for fixation on a patient, an elongated sleeve coupled to the fixation structure and sized and shaped for insertion into a patient's vasculature, and a valve at a distal end of the internal lumen. When a hemodialysis catheter is inserted into the device and coupled to the proximal end, distal movement of the proximal end relative to the fixation structure biases a distal end of the hemodialysis catheter from a position inside the elongated sleeve through a valve out of the device and into the patient's blood.

Abstract: Embodiments of the disclosure include lubricious coatings. In an embodiment the disclosure includes a lubricious coating for a medical device including an acrylic acid polymer, an acrylamide copolymer comprising at least one photoreactive group, and a cross-linking agent comprising at least two photoreactive groups. The coating can be used on a catheter surface to facilitate its movement in the body.

Abstract: Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a vinyl amine polymer. Methods of making the delivery composition, as well as kits and methods of use are also included herein.